Pharmaceutical formulation containing gelling agent
First Claim
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1. A controlled release oral solid dosage form comprising:
- (i) a first population of coated particles comprising an opioid analgesic coated with a controlled release material, and(ii) a second population of coated particles comprising polyethylene oxide coated with an acrylic polymer,the dosage form providing a therapeutic effect for about 12 hours to about 24 hours when orally administered to a human patient, and when dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid, forming a viscous gel,wherein the coated particles of the second population are about 0.5 mm to about 2 mm in diameter and are free from the opioid analgesic.
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Abstract
Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
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Citations
24 Claims
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1. A controlled release oral solid dosage form comprising:
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(i) a first population of coated particles comprising an opioid analgesic coated with a controlled release material, and (ii) a second population of coated particles comprising polyethylene oxide coated with an acrylic polymer, the dosage form providing a therapeutic effect for about 12 hours to about 24 hours when orally administered to a human patient, and when dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid, forming a viscous gel, wherein the coated particles of the second population are about 0.5 mm to about 2 mm in diameter and are free from the opioid analgesic. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A controlled release oral solid dosage form comprising a capsule containing:
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(i) a first population of coated particles comprising an opioid analgesic coated with a controlled release material, and (ii) a second population of coated particles comprising polyethylene oxide coated with an acrylic polymer, the dosage form providing a therapeutic effect for about 12 hours when orally administered to a human patient, and having a viscosity unsuitable for injection when dissolved in from about 0.5 ml to about 10 ml of water, wherein the coated particles of the second population are about 0.5 mm to about 2 mm in diameter and are free from the opioid analgesic. - View Dependent Claims (18, 19, 20)
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21. A controlled release oral solid dosage form comprising a capsule containing:
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(i) a first population of coated particles comprising an opioid analgesic coated with a controlled release material, and (ii) a second population of coated particles comprising polyethylene oxide coated with an acrylic polymer, the dosage form providing a therapeutic effect for about 12 hours to about 24 hours when orally administered to a human patient, and when dissolved in from about 0.5 ml to about 10 ml of water, forming a viscous gel, wherein the coated particles of the second population are about 0.5 mm to about 2 mm in diameter and are free from the opioid analgesic. - View Dependent Claims (22, 23, 24)
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Specification